This section highlights FDA-related milestones and regulatory updates for drugs developed by Firefly Neuroscience (AIFF).
Over the past two years, Firefly Neuroscience has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BNA™ and SP-624-103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BNA™ technology - FDA Regulatory Timeline and Events
BNA™ technology is a drug developed by Firefly Neuroscience for the following indication: To assess patients' brain age.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BNA™ technology
- Announced Date:
- January 24, 2025
- Indication:
- To assess patients' brain age.
Announcement
Firefly Neuroscience, Inc is pleased to highlight two impactful studies that demonstrate the utility of advanced Resting Electroencephalograms (EEG) and Cognitive EEG (ERP) data analytics in drug development and neuropsychiatric care..
AI Summary
Firefly Neuroscience, Inc. has highlighted two impactful studies showcasing the benefits of using advanced EEG data analytics in drug development and brain health care. The first study focused on a new drug, MIJ821, which demonstrated dose-dependent changes in resting EEG signals. These changes not only confirmed the drug's effect on brain activity but also pointed to its potential as a useful tool for target engagement and dose selection in clinical trials.
The second study explored how the company’s technology assesses cognitive changes in patients with major depressive disorder. The study found that baseline differences in brain activation normalized after treatment, suggesting improved cognitive function. Overall, Firefly’s BNA™ system can provide objective measures of drug efficacy and cognitive change, which could help personalize treatment strategies and drive innovation in neuropsychiatric care.
Read Announcement- Drug:
- BNA™ technology
- Announced Date:
- January 14, 2025
- Indication:
- To assess patients' brain age.
Announcement
Firefly Neuroscience, Inc. announced the advancement of research to assess a patient's brain age - an estimation of the biological age of a person's brain – via its FDA-cleared BNA™ technology platform.
AI Summary
Firefly Neuroscience, Inc. has advanced its research on measuring a patient’s brain age using its FDA-cleared Brain Network Analytics (BNA™) technology platform. This innovative method estimates the biological age of the brain through analysis of both Resting EEG and Cognitive EEG (ERP) data, marking a breakthrough in the field.
The system’s ability to compare brain age with the patient’s chronological age could prove to be an important tool in identifying early signs of dementia and other neurological conditions. By utilizing this approach, researchers hope to enhance the early screening and ongoing monitoring of patients, potentially leading to more proactive treatments, especially for conditions like Alzheimer’s. Firefly’s advancement represents a significant step forward in applying artificial intelligence to brain health and paves the way for further innovations in diagnostic and treatment methods.
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SP-624-103 - FDA Regulatory Timeline and Events
SP-624-103 is a drug developed by Firefly Neuroscience for the following indication: For Depression and Cognition.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SP-624-103
- Announced Date:
- January 10, 2025
- Indication:
- For Depression and Cognition
Announcement
Arrivo BioVentures today announced positive data from its SP-624-103 study evaluating the impact of SP-624's novel epigenetic mechanism of action on neurological pathways.
AI Summary
Arrivo BioVentures announced positive data from its SP-624-103 study, which evaluated the novel epigenetic mechanism of SP-624 on neurological pathways. In this study, healthy subjects received a single 20mg dose of the drug, and the results showed a significant increase in brain activity. Specifically, there was an increase in beta power, mostly in the frontal-central regions, which suggests improved synaptic plasticity and neuronal connectivity. In addition, a decrease in delta power was observed, a change often linked to better cortical arousal and fewer depressive symptoms. The study also noted enhanced neural efficiency in early perceptual processing, suggesting that this treatment could improve cognitive processing and decision-making speed. These promising findings support SP-624’s potential in treating major depressive disorder, especially in female patients, by normalizing cortical activity and improving overall brain function.
Read Announcement
